Applied Medical

Regulatory Affairs Associate

Category (Portal Searching) Regulatory Affairs/ Quality
Job Locations NL-Amersfoort

Overview

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At Applied Medical, we are committed to make a meaningful, positive difference, each and every day. Within our European headquarters in Amersfoort (NL), we develop, manufacture and support the implementation of our advanced medical devices across Europe and the MENA region. Applied’s team members enjoy working in an environmentally friendly and international environment, in which people of diverse backgrounds are valued, challenged, and acknowledged. We support our team members by giving them opportunities of ongoing learning and education, possibilities to take part in community volunteering activities and a variety of onsite exercise classes and health activities.

 

If you are passionate about working in an organization that allows you to make decisions based upon what is right for the patient, customer, community and environment, Applied Medical is the place for you.

Job Description

Are you enthusiastic to pursue and build your career in regulatory affairs? This position allows you to do so! If you have an affinity with medical devices or regulatory affairs and a strong drive to develop yourself, we invite you to apply. As Regulatory Affairs Associate, you will provide administrative support to Regulatory Affairs Specialist(s) and help ensure regulatory compliance. You will be part of our Regulatory Affairs team that is based at our European Headquarters in Amersfoort, and you will report to the Team Leader.

 

Within Applied Medical the title of this position is Associate Regulatory Affairs Specialist.

 

Key responsibilities

  • Provide administrative support to the RA specialists within the team
  • Maintain current knowledge of medical device regulations, guidance, and standards applicable to medical devices within the defined portfolio
  • Help prepare regulatory documents, dossiers, and applications to be maintained in the market as required by legislation and applicable SOPs
  • Maintain and monitor required regulatory compliance databases, files, systems, and processes
  • Participate in improvement activities and make recommendations for process improvements
  • Work closely together with other departments such as Customer Service, Sales and Clinical Development to deliver company objectives 

Requirements

  • Bachelor’s or master’s degree in a relevant area such as regulatory, quality, engineering, or life Sciences
  • Experience in or affinity with medical devices and/or regulatory affairs
  • Able and enthusiastic to develop an understanding of medical regulations, European Medical Device Directives, and other global regulations
  • Strong verbal and written English communication skills, any other European language is an advantage
  • Good knowledge of Microsoft Office
  • Enthusiastic to work in an international environment

We Offer

  • Good remuneration package including pension and 27 vacation days
  • Travel allowance and health insurance benefits
  • Opportunity for personal development and continuous learning
  • Education reimbursement program
  • An informal and international work environment with over 35 nationalities
  • Teambuilding and volunteer opportunities
  • Onsite group exercise classes and health activities
  •  

Interested?

 

Are you an individual who thrives in a fast-paced, challenging, and professional, yet casual business environment? We are looking forward to receiving your application. For more information regarding our hiring process, click here.

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